地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251684484168522816992821701812169918116939970.50
210.311694638168697916908080.33
单位质量响应值RSD%判断
165268.00163996.900.55数据可信
供试品溶液-2批-0.5tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11689144-1689144102.50098.372.33102.5098.372.33
21640066-164006699.52299.52
31598180-159818096.98096.98
41606407-160640797.47997.48
51605801-160580197.44297.44
61587082-158708296.30796.31
10min11658595-1658595100.646101.091.59101.78102.181.57
21684410-1684410102.213103.32
31693826-1693826102.784103.86
41631310-163131098.990100.07
51687319-1687319102.389103.47
61640325-164032599.537100.61
15min11658614-1658614100.647100.431.48102.90102.641.46
21666742-1666742101.140103.38
31680483-1680483101.974104.19
41612297-161229797.837100.02
51669039-1669039101.280103.50
61643137-164313799.708101.88
20min11676882-1676882101.756100.390.89105.13103.720.90
21648409-1648409100.028103.39
31663254-1663254100.929104.28
41633982-163398299.153102.42
51655656-1655656100.468103.81
61647811-164781199.992103.28
30min11645700-164570099.86499.740.90104.37104.190.90
21653410-1653410100.331104.81
31650222-1650222100.138104.61
41619101-161910198.250102.62
51659474-1659474100.699105.16
61634286-163428699.171103.57
45min11665648-1665648101.074100.201.50106.69105.761.47
21667199-1667199101.168106.76
31657313-1657313100.568106.16
41607606-160760697.552103.02
51672129-1672129101.467107.05
61637315-163731599.355104.85
60min11652676-1652676100.28799.661.33107.03106.321.32
21659385-1659385100.694107.41
31655850-1655850100.480107.18
41605555-160555597.428103.97
51654907-1654907100.422107.13
61625377-162537798.630105.23
极限11641840-164184099.62999.251.30107.48107.021.29
21654985-1654985100.427108.26
31639104-163910499.463107.28
41600725-160072597.134104.76
51655538-1655538100.461108.28
61621173-162117398.375106.07
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251704353170337117055921696151169997417018880.23
210.311719169171220117156850.29
单位质量响应值RSD%判断
166037.85166409.800.16数据可信
供试品溶液-2批-0.5tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11682876-1682876101.140101.233.03101.14101.233.03
21690323-1690323101.588101.59
31695486-1695486101.898101.90
41768443-1768443106.283106.28
51614084-161408497.00697.01
61655276-165527699.48299.48
10min11658744-165874499.690100.451.63100.81101.571.62
21706037-1706037102.532103.66
31650405-165040599.189100.32
41678626-1678626100.885102.07
51637185-163718598.39499.47
61697026-1697026101.991103.10
15min11669454-1669454100.334100.570.69102.57102.810.69
21669660-1669660100.346102.61
31674430-1674430100.633102.87
41675835-1675835100.717103.02
51657925-165792599.641101.81
61692919-1692919101.744103.98
20min11686076-1686076101.333100.461.27104.68103.821.22
21664336-1664336100.026103.41
31649136-164913699.113102.47
41652459-165245999.312102.73
51672029-1672029100.489103.77
61704796-1704796102.458105.83
30min11674797-1674797100.655100.200.92105.13104.670.91
21656312-165631299.544104.04
31654747-165474799.450103.90
41673880-1673880100.600105.12
51652654-165265499.324103.72
61690969-1690969101.627106.13
45min11662483-166248399.915100.321.55105.51105.911.51
21662191-166219199.897105.50
31649495-164949599.134104.69
41717390-1717390103.215108.86
51647634-164763499.022104.52
61676067-1676067100.731106.37
60min11669215-1669215100.31999.520.85107.02106.220.84
21661579-166157999.861106.57
31636777-163677798.370105.03
41658694-165869499.687106.48
51640474-164047498.592105.19
61668438-1668438100.273107.03
极限11660979-166097999.82499.610.92107.64107.420.92
21649676-164967699.145106.97
31640104-164010498.570106.32
41671478-1671478100.455108.35
51644120-164412098.811106.51
61677662-1677662100.827108.70
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251759066176009117609921752250175223817569270.25
210.311741551171874817301500.94
单位质量响应值RSD%判断
171407.51167812.801.50数据可信
供试品溶液-2批-0.5tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11556918-155691891.71292.271.4791.7192.281.46
21598524-159852494.16394.16
31562288-156228892.02992.03
41541695-154169590.81690.82
51548993-154899391.24691.25
61590256-159025693.67693.68
10min11640745-164074596.65096.260.8497.6797.280.83
21634165-163416596.26397.31
31618344-161834495.33196.35
41635441-163544196.33897.35
51655328-165532897.50998.52
61620326-162032695.44896.49
15min11632713-163271396.17795.880.4498.2797.980.44
21633756-163375696.23998.35
31632428-163242896.16098.24
41615963-161596395.19197.27
51622439-162243995.57297.67
61629133-162913395.96698.07
20min11637063-163706396.43396.210.5199.6099.370.50
21635132-163513296.32099.50
31631184-163118496.08799.24
41633131-163313196.20299.34
51644232-164423296.856100.01
61619118-161911895.37698.54
30min11662555-166255597.93596.031.25102.17100.261.20
21617538-161753895.28399.54
31639059-163905996.551100.77
41603842-160384294.47798.68
51634941-163494196.308100.54
61623541-162354195.63799.86
45min11631880-163188096.12895.791.03101.45101.091.00
21622528-162252895.577100.89
31638317-163831796.507101.80
41594187-159418793.90899.16
51638042-163804296.491101.80
61631856-163185696.127101.42
60min11618250-161825095.32595.771.31101.71102.131.24
21608104-160810494.728101.10
31654032-165403297.433103.80
41598412-159841294.157100.46
51633208-163320896.206102.58
61642416-164241696.749103.11
极限11620313-162031395.44795.120.81102.90102.550.79
21612619-161261994.994102.42
31622252-162225295.561103.01
41590045-159004593.664101.01
51626176-162617695.792103.24
61617511-161751195.282102.71
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251764670176207917560551747377174565117551660.49
210.311798979178662117928000.49
单位质量响应值RSD%判断
171235.71173889.431.09数据可信
供试品溶液-1批-0.5tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11258288-125828872.84976.437.6672.8576.437.66
21427536-142753682.64882.65
31289384-128938474.64974.65
41335273-133527377.30677.31
51435749-143574983.12383.12
61174643-117464368.00768.01
10min11522956-152295688.17292.522.8988.9893.362.89
21599387-159938792.59793.52
31570876-157087690.94791.78
41653910-165391095.75496.61
51629138-162913894.32095.24
61611581-161158193.30394.06
15min11557468-155746890.17092.672.1191.9694.552.11
21592958-159295892.22594.17
31571694-157169490.99492.83
41607608-160760893.07395.00
51646353-164635395.31697.29
61628255-162825594.26996.06
20min11569367-156936790.85992.461.8293.6595.371.79
21597707-159770792.50095.47
31562222-156222290.44693.30
41607003-160700393.03896.00
51602945-160294592.80395.83
61642900-164290095.11697.96
30min11468179-146817985.00188.962.7388.8092.892.68
21504272-150427287.09191.09
31542361-154236189.29693.15
41571272-157127290.97094.96
51570078-157007890.90094.96
61562725-156272590.47594.37
45min11489065-148906586.21089.662.0190.9694.592.01
21559906-155990690.31195.28
31542838-154283889.32394.17
41574631-157463191.16496.17
51557617-155761790.17995.25
61568066-156806690.78495.69
60min11515571-151557187.74589.311.4193.4595.231.43
21530289-153028988.59794.57
31524937-152493788.28794.13
41568026-156802690.78296.80
51555950-155595090.08296.16
61561159-156115990.38496.29
极限11481144-148114485.75288.292.3092.4395.202.27
21510118-151011887.42994.38
31496633-149663386.64893.47
41550341-155034189.75896.78
51573771-157377191.11498.19
61537796-153779689.03195.95
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251787404176055817631821769818175962517681170.66
210.311805513180575818056360.01
单位质量响应值RSD%判断
172499.22175134.431.08数据可信
供试品溶液-1批-0.5tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11533537-153353788.14491.782.9788.1491.782.97
21673037-167303796.16296.16
31570960-157096090.29590.30
41622573-162257393.26293.26
51591406-159140691.47091.47
61588972-158897291.33091.33
10min11634315-163431593.93795.962.6594.9296.982.65
21749809-1749809100.575101.64
31641097-164109794.32695.33
41651697-165169794.93695.97
51648366-164836694.74495.76
61691858-169185897.24498.26
15min11655538-165553895.15694.462.4097.1896.542.38
21716461-171646198.658100.84
31626627-162662793.49595.55
41614406-161440692.79294.88
51636837-163683794.08196.15
61610428-161042892.56494.66
20min11614147-161414792.77794.032.4095.8697.172.39
21713062-171306298.463101.74
31613010-161301092.71295.80
41635229-163522993.98997.11
51609960-160996092.53795.65
61630596-163059693.72396.85
30min11565516-156551689.98291.512.1794.0995.692.18
21660592-166059295.44799.82
31574810-157481090.51694.64
41585302-158530291.11995.29
51586662-158666291.19895.34
61579355-157935590.77894.94
45min11550943-155094389.14491.303.0094.2696.492.95
21679403-167940396.528101.96
31555082-155508289.38294.51
41586970-158697091.21596.39
51566671-156667190.04895.20
61591305-159130591.46496.64
60min11566515-156651590.04090.862.9896.1497.072.93
21663972-166397295.641102.15
31541515-154151588.60394.72
41575865-157586590.57796.77
51536460-153646088.31294.47
61600610-160061091.99998.19
极限11579271-157927190.77390.912.9297.8798.142.87
21667567-166756795.848103.42
31537505-153750588.37295.48
41582718-158271890.97198.17
51546381-154638188.88296.02
61577011-157701190.64397.86
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251703310170648917056921705240170247817046420.10
210.311725820172605817259390.01
单位质量响应值RSD%判断
166306.54167404.360.47数据可信
供试品溶液-1批-0.5tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11528694-152869491.52793.911.8691.5393.911.86
21591571-159157195.29295.29
31582830-158283094.76994.77
41555184-155518493.11393.11
51547720-154772092.66692.67
61604575-160457596.07096.07
10min11676395-1676395100.37199.970.73101.39101.020.73
21671007-1671007100.048101.11
31682915-1682915100.761101.81
41647716-164771698.65399.69
51666054-166605499.751100.78
61674422-1674422100.252101.32
15min11650520-165052098.82199.391.34100.95101.541.33
21649484-164948498.759100.93
31704890-1704890102.077104.25
41646519-164651998.582100.71
51656240-165624099.164101.30
61652205-165220598.922101.10
20min11633357-163335797.79497.401.66101.02100.651.63
21601168-160116895.86699.13
31672442-1672442100.134103.44
41598508-159850895.70798.93
51623068-162306897.178100.42
61631857-163185797.704100.98
30min11612419-161241996.54097.470.99100.86101.810.99
21618784-161878496.921101.25
31648935-164893598.726103.15
41611979-161197996.514100.80
51644298-164429898.449102.77
61630973-163097397.651102.02
45min11605371-160537196.11896.370.50101.51101.800.48
21623043-162304397.176102.59
31612638-161263896.553102.07
41610864-161086496.447101.81
51600303-160030395.815101.23
61605139-160513996.104101.56
60min11510459-151045990.43594.032.2696.89100.522.15
21563708-156370893.624100.11
31589147-158914795.147101.74
41577132-157713294.427100.86
51564684-156468493.682100.16
61617434-161743496.840103.36
极限11594653-159465395.47694.201.61102.94101.741.47
21566633-156663393.799101.33
31591603-159160395.294102.94
41575443-157544394.326101.81
51585379-158537994.921102.44
61526370-152637091.38898.98
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